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A Study of BAY 3670549 for Atrial Fibrillation

This study is testing a medicine called BAY 3670549 for people with atrial fibrillation (AF), a condition where the heart beats irregularly. The main goals are to see how well BAY 3670549 works, how safe it is, and how your body handles it. You would receive a single intravenous (IV) infusion of either BAY 3670549 or a placebo (a treatment with no active medicine). Researchers will then check if your heart rhythm returns to normal. If it doesn't, you can still have electrical cardioversion, a procedure to help your heart return to a normal rhythm. This study is for adults aged 18 to 85 who are stable and have had AF for at least 3 hours but no more than 30 days. The study aims to enroll 360 participants.

Study design
This is an interventional study comparing BAY 3670549 to a placebo, with a planned enrollment of 360 participants. The phase of the study is not specified.
What's involved
You would receive a single intravenous (IV) infusion of either BAY 3670549 or a placebo. You would then be observed to see if your heart rhythm returns to normal.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured up to 3 hours after the start of the study intervention administration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07625215

A Study to Test How Well BAY 3670549 Works and How Safe it is in Patients With Atrial Fibrillation

Recruiting
PHASE2Ages 18–85InterventionalTreatment
Bayer
~360 participants
Updated 2026-09-09 on ClinicalTrials.gov
What's tested:BAY 3670549Placebo

At a glance

Recruiting sites
1 of 29 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with conversion from atrial fibrillation (AF) to sinus rhythm (SR), sustained for ≥1 minute, within 3 hours after start of study intervention administration, and prior to use of rescue therapy or other SoC for cardioversion
Measured over Up to 3 hours after start of administration of study intervention

Conditions

Atrial Fibrillation

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Atrial Fibrillation

NCT07625215

Where you'd take part

This study runs at 29 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • American Heart of Poland S.A. - MCSN, PAKS w Chrzanowie - Oddział Intensywnej Opieki Kardiologicznej

    Chrzanów, Polandno site contact published

    Not yet recruiting

  • American Heart of Poland S.A. - PAKS Centrum Kardiologii i Kardiochirurgii w Bielsku-Białej - Oddział Kardiologii

    Bielsko-Biala, Polandno site contact published

    Not yet recruiting

  • AZ Delta | Clinical Trial Center - Cardiology

    Roeselare, West Flanders, Belgiumno site contact published

    Not yet recruiting

  • Azienda Ospedaliero Universitaria Delle Marche - Clinica di Cardiologia e Aritmologia

    Torrette, Italyno site contact published

    Not yet recruiting

  • Azienda Ospedaliero-Universitaria Policlinico Umberto I - Malattie Cardiovascolari

    Roma, Italyno site contact published

    Not yet recruiting

  • Centro Cardiologico Monzino S.p.A. - UO Scompenso e Cardiologia Clinica

    Milan, Italyno site contact published

    Recruiting

  • Duke University Hospital - Cardiology

    Durham, North Carolinano site contact published

    Not yet recruiting

  • Ente Ecclesiastico Ospedale Generale Regionale Miulli - Cardiologia e UTIC

    Acquaviva delle Fonti, Italyno site contact published

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Bayer Clinical Trials Contact
[email protected]
18888422937
Email the study team

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Eligibility criteria

Inclusion

Participant must be 18 to 85 years of age inclusive, at the time of signing the informed consent.
Participant is hemodynamically stable and does not require emergency cardioversion, as determined by the investigator.
Participant has a current episode of atrial fibrillation (AF) ongoing for at least 3 hours and no more than 30 days at the time of randomization.
Participant has an indication for electrical cardioversion of AF, as determined by the investigator according to standard clinical practice and national/institutional guidelines.
At randomization, successful initiation and achievement of therapeutic levels of anticoagulation therapy, as well as completion of imaging evaluation for left atrial thrombi, as appropriate for the duration of the AF episode and risk for the participant according to national guideline and institution-specific routine practice.
BMI within range \[18 - 39.9\] kg/m2.
Contraceptive use by participants or participant partners should be consistent with the study protocol and local regulations regarding the methods of contraception for those participating in clinical studies.
Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
Willing and able to comply with the receipt, home use, and return of the continuous ECG recording device, as well as with the participation in scheduled telephone follow-up assessments.

Exclusion

Current atrial flutter (AFL) or combined AF/AFL
Contraindication for electrical cardioversion on planned treatment day
Documented severely dilated left atrium (left atrial diameter, LAD \>5 cm) measured by any modality within the 6 months prior to screening; if several values are available, the most recent one shall be reported. If left atrium diameter was not measured in the last 6 months or a major cardiovascular event occurred within the last 6 months, a new measurement must be done at screening
Unsuccessful conversion of current AF episode (pharmacologically or electrically)
Known severe valvular heart disease (e.g., severe mitral regurgitation, severe aortic stenosis)
Patients with NYHA Class ≥ III heart failure, or with active management of acute heart failure decompensation on treatment day.
History within the preceding 3 months prior to randomization of any of the following events, or any other significant cardiovascular event as judged by the investigator:
Stroke
Myocardial infarction
Unstable angina pectoris or other signs of myocardial ischemia
Cardiac surgery
Transcatheter valve replacement
Percutaneous coronary intervention (PCI)
Coronary artery bypass graft (CABG) or other revascularization procedure
Severe renal impairment, i.e., estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m² (using CKD-EPI formula) or requiring dialysis
Severe hepatic impairment, i.e. Child Pugh Class C
Use of anti-arrhythmic class I or III drugs within 5 half-lives before study drug administration (oral amiodarone in the previous 3 months)
Hypertension with SBP ≥ 180 mmHg or hypotension (SBP \< 90 mmHg) at randomization (based on the second BP measurement)
Stressor-associated AF, i.e., in the setting of an acute and reversible stressor (e.g., cardiac surgery, myocarditis, endocarditis, sepsis, pneumonia, etc.). This includes ablation procedure within the preceding one month prior to randomization.

What this trial measures

  • Number of Participants with conversion from atrial fibrillation (AF) to sinus rhythm (SR), sustained for ≥1 minute, within 3 hours after start of study intervention administration, and prior to use of rescue therapy or other SoC for cardioversionUp to 3 hours after start of administration of study intervention

    AF = atrial fibrillation ; SR = sinus rhythm ; SoC = Standard of Care;